Reported Mar 26, 2014 · Terminated
Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069. The Reusable Clip…
Atricure Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Atricure Inc · 6217 Centre Park Drive · West Chester, OH · 45069
Is this the product you have?
- Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069. The Reusable Clip Applier (Applier) is intended to be used to deploy the Gillinov-Cosgrove LAA Clip (Clip). The Gillinov-Cosgrove LAA Clip (Clip) is an implantable device used for occlusion of the left atrial appendage.
- Lot codes and dates
- Lot Number MFR-0424-1
- Amount recalled
- 46 units
Where it was sold
Why it was recalled
The firm was notified by a customer of a cracked spring in the handle of the RCD1 device.
This product could cause temporary or reversible health problems — stop using it.
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